Meet Astria Therapeutics, born from the ashes of Catabasis, a company burned by its doomed Duchenne muscular dystrophy (DMD) hopeful edasalonexent, which failed multiple efforts to help patients with the muscle-wasting disease, while others like Sarepta found a way through to approval.
The final nail in the coffin for the drug came last fall when a phase 3 test, known as PolarisDMD, saw edasalonexent miss both its primary and secondary endpoints. The company hoped that the oral NF-kB inhibitor would help a broad range of DMD patients, but this failure, on top of the first back in 2017, put that hope to bed.
These failures also led to staff cuts, plunging shares and halted work on edasalonexent, leaving it a zombie biotech. There was also talk of “strategic options” last October, which is usually a death knell for a company.
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Nearly a year later, and what we have is a new name and a pivot to a new R&D strategy. From the failure that was Catabasis comes Astria (from the Greek for “star”), a new ticker symbol (“ATXS”) and a major rewind from being a late-stage biotech focused on DMD to a preclinical company now working on an asset known as STAR-0215 in hereditary angioedema (HAE).
The change comes after Astria bought out Quellis at the start of the year along with STAR-0215, or what was QLS-215, essentially incorporating this young startup into its shell and being reborn.
The drug is a long-acting monoclonal antibody inhibitor of plasma kallikrein and for HAE is dosed once every three months or longer. The market is already well catered for, with the likes of CSL Behring, Takeda and others already selling HAE treatments.
Astria, however, says its aim is to develop the “most patient-friendly” preventive treatment option for people living with HAE. This is a rare inherited disorder characterized by recurrent episodes of the accumulation of fluids outside of the blood vessels and can cause sudden swelling across the body.
The company added that it expects to file for approval to kick-start STAR-0215 trials in mid-2022, with phase 1’s initial proof-of-concept results expected by the end of next year.
“The name Astria embodies our commitment to put patients first in all that we do,” said Jill Milne, Ph.D., CEO at Astria.
“Following the acquisition of Quellis earlier this year, our company is focused on tackling the debilitating disease hereditary angioedema, with the broader goal of addressing the unmet needs of patients with rare and niche allergic and immunological diseases.
“We are advancing STAR-0215 as a differentiated and potentially the most patient-friendly preventative treatment option with dosing once every three months or longer. We are proud to launch Astria Therapeutics and bring our team’s combination of experience, passion and compassion to our future vision and our commitment to patients and their families.”